Studying Changes in Physical Function Measures in Stem Cell Transplant Patients at Risk for Steroid Myopathy

Not Applicable

Terminated

• Conditions: Acute Graft Versus Host Disease
• Interventions: Behavioral: Exercise Intervention; Other: Physical Performance Testing; Other: Questionnaire Administration

• Registration Number: NCT04521777
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This trial investigates the changes in physical and functional tests over time in patients with suspected acute graft versus host disease (from a hematologic stem cell transplant) who started treatment with corticosteroids. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Steroids are used to treat suspected graft-versus-host disease. Steroid myopathy (muscle weakness and fatigue) is a significant side effect of high dose steroid therapy, and can impair activities of daily of life. The goal of this trial is to learn how patients' physical activities and functions change over time while on GVHD-steroid treatment.

Detailed Description

PRIMARY OBJECTIVE:

I. To perform a pilot study to estimate the change in six physical and functional tests over time in patients with suspected acute graft-versus-host disease (GVHD) who have been initiated on treatment with corticosteroids.

SECONDARY OBJECTIVES:

I. To describe and potentially define steroid myopathy by following the patterns of the muscle loss and functional impairment in this population of patients.

II. To follow steroid myopathy and describe its incidence, its severity, and the impact on non-relapse mortality in a homogeneous population of patients with suspected acute graft-versus-host disease (GVHD) who have been initiated on treatment with corticosteroids at a quaternary institution in the inpatient and outpatient setting.

III. To estimate the adherence to an intermittently supervised exercise program in hematopoietic stem cell transplantation (HSCT) patients who are at risk of developing steroid myopathy.

OUTLINE:

Patients complete a physical function test over 15 minutes at baseline, and at days 14, 28, and 56. Patients also participate in an 8-week home-based strengthening and walking program consisting of a strengthening/resistance program for 30 minutes, 3 times a week, and walking program for 20-30 minutes at least 3 times a week.

Study Timeline

• Study Start: 2015-10-01
• Primary Completion: 2017-05-08
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-21
• Results First Submitted: 2020-11-09
• Results First Submitted QC: 2021-01-05
• Results First Posted: 2021-01-27
• Status Verified: 2021-03
• Study Completion: 2021-03-18
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Participants are willing and able to give written informed consent and to comply with all of the study visits and procedures
• Age >= 55 years, or with a Sorror co-morbidity index of >= 3
• Post allogenic hematopoietic stem cell transplantation using bone marrow, peripheral blood or cord blood; or after pre planned donor lymphocyte infusion
• Presumptive diagnosis of acute GVHD necessitating high-dose corticosteroid treatment (with an approximate starting dose of methylprednisolone equivalent of 2 mg/kg/day)
• Within 5 days of receiving corticosteroid treatment
• ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 or equivalent Karnofsky score of 60 or higher
• The patient is referred to the study by their stem cell transplant attending physician

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Exclusion Criteria

• Non-English speaking
• Underlying unstable cardiac or pulmonary disease in the opinion of the investigator that limits participant involvement in exercise
• Has a pre-transplant echocardiogram with ejection fraction < 45%
• Requires supplemental oxygen to maintain oxygen (O2) saturation > 92%
• Musculoskeletal injury that precludes participation in an exercise program
• Inability to participate in a structured exercise program
• Patients for whom the physician feels is unsafe for an exercise program
• Platelets equal to or less than 10,000 or evidence of active bleeding
• Patients who are unable to understand or follow through with the exercise program

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (exercise intervention)	Exercise Intervention	Patients complete a physical function test over 15 minutes at baseline, and at days 14, 28, and 56. Patients also participate in an 8-week home-based strengthening and walking program consisting of a strengthening/resistance program for 30 minutes, 3 times a week, and walking program for 20-30 minutes at least 3 times a week.
Supportive care (exercise intervention)	Questionnaire Administration	Patients complete a physical function test over 15 minutes at baseline, and at days 14, 28, and 56. Patients also participate in an 8-week home-based strengthening and walking program consisting of a strengthening/resistance program for 30 minutes, 3 times a week, and walking program for 20-30 minutes at least 3 times a week.
Supportive care (exercise intervention)	Physical Performance Testing	Patients complete a physical function test over 15 minutes at baseline, and at days 14, 28, and 56. Patients also participate in an 8-week home-based strengthening and walking program consisting of a strengthening/resistance program for 30 minutes, 3 times a week, and walking program for 20-30 minutes at least 3 times a week.

Primary Outcome Measures

Name	Time	Method
5 Times Sit to Stand (5xSTS)	Baseline, Day 14, Day 28 and Day 56	5xSTS was measured in seconds on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0.
6 Minutes Walk Test	Baseline, Day 14, Day 28 and Day 56	6 minute walk test (measured in meters) was conducted on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0, and Day 56 minus Day 0.
Knee Extensors Strength	Baseline, Day 14, Day 28 and Day 56	Knee Extensors Strength (in pounds) was measured on Baseline, Day 14, Day 28 and Day 56 and measured the median change for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0.
Brooke Scale for Myopathy	Baseline, Day 14, Day 28 and Day 56	Brooke Scale for myopathy (a score from 0 to 6, with 6 being the best score with full range of motion of the arms) was measured on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0
Modified Adult Myopathy Assessment Tool	Baseline, Day 14, Day 28 and Day 56	The modified Adult Myopathy Assessment Tool assigns a numerical score to a series of physical tasks (arm raise \[0 to 3\], sustained arm raise \[0 to 4\], single sit-to-stand \[0 to 3\], sustained hip flexion \[0 to 4\], and sustained knee extension \[0 to 4\]). The total score of all test components (0 to 18) is reported, with 18 as the highest score for muscle function and endurance.
Hip Flexors Strength	Baseline, Day 14, Day 28 and Day 56	Hip Flexors Strength (in pounds) was measured on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States